SUNSCREEN SPF 30- avobenzone, homosalate, octocrylene, octisalate lotion

Sunscreen SPF 30 by

Drug Labeling and Warnings

Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Tempo Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octocrylene 10%, Octisalate 5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

WARNINGS:

Spending time in the sun increases your risk of skin cancer or early skin aging. This product has been shown only to prevent sunburn skin cancer or early skin aging. This product is water resistant or sweat resistant. Skin Cancer/Skin Aging Alert:NOTNOT

For external use only.

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor 

if rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Non-Water Resistant Product

Spending time in the sun increases our risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measuress including: Sun Protection Measures.

• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating 
• Reapply at least every 2 hours
• Children under 6 months: Ask a doctor

• Limit time in the sun, especially from 10 a.m. to 2 p.m.
• Wear long sleeve shirts, pants, hats and sunglasses.

Inactive Ingredients

Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

Other Information

• Protect this product from excessive heat and direct sun

Package Labeling:53ml

Package Labeling:30ml

INGREDIENTS AND APPEARANCE

SUNSCREEN SPF 30 
avobenzone, homosalate, octocrylene, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80524-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
LEVOMENOL (UNII: 24WE03BX2T)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80524-002-53	53 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2020
2	NDC: 80524-002-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/18/2020

Labeler - Tempo Industries, Inc. (883232993)